Montage-XT Settable Bone Putty— 510(k) K243506
Substantially EquivalentOrthocon, Inc.
FDA 510(k) clearance K243506 for Montage-XT Settable Bone Putty, Substantially Equivalent on 2024-11-18. Applicant: Orthocon, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthocon, Inc.
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Stamford, CT, US
Recent devices under product code MQV
view allMore clearances from Orthocon, Inc.
view all- K262769 — Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)
- K261265 — Permatage XT Settable Bone Putty
- K261439 — Permatage Flowable, Settable Hemostatic Bone Paste
- K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
- K253732 — Permatage Flowable, Settable Bone Paste
Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.